Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen

Phase 2 Completed 262 enrolled Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study was to compare the effects on bones of the following two drug combinations: * maraviroc (MVC), emtricitabine (FTC), plus darunavir/ritonavir (DRV/r) * tenofovir (TDF) plus emtricitabine (FTC) plus darunavir/ritonavir (DRV/r) Additional study objectives were the following: * To see how the drug combinations affect the brain and kidneys. * To see how well the drug combinations lower the HIV viral load. * To see how safe the drug combinations are, how well people are able to take the study drug combinations, and how well their immune systems respond to the study drugs.

Timeline

Start: 2012-01-17
Primary completion: 2014-06-30
Completion: 2014-06-30

Outcome

Met primary endpoint

paper The decline in hip BMD (n = 115 for MVC, n = 109 for TDF) at week 48 was less with MVC PMID 26060295 ↗

paper vs -2.40% [-4.30%, -1.32%] for TDF (P < .001). PMID 26060295 ↗

Publications

Taiwo BO, Chan ES, Fichtenbaum CJ, Ribaudo H, Tsibris A, Klingman KL, Eron JJ, Berzins B, Robertson K, Landay A, Ofotokun I, Brown T; AIDS Clinical Trials Group A5303 Study Team. Less Bone Loss With Maraviroc- Versus Tenofovir-Containing Antiretroviral Therapy in the AIDS Clinical Trials Group A5303 Study. Clin Infect Dis. 2015 Oct 1;61(7):1179-88. doi: 10.1093/cid/civ455. Epub 2015 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Maraviroc	Other / unclassified	150 mg	Oral
Subject	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral
Background	Darunavir	Small molecule	800 mg	Oral
Background	Ritonavir	Other / unclassified	100 mg	Oral
Background	emtricitabine	Other / unclassified	200 mg	Oral